Senior Clinical Research Associate, Soft Tissue Ablation

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and track activities that facilitate the successful execution of soft tissue ablation clinical trials

• Assist in planning studies and initiating site activities

• Monitor patient recruitment, data integrity, protocol compliance, subject safety, and site-related activities

• Provide on-site clinical monitoring and procedural case support across various studies

• Collaborate with investigators, research personnel, and cross-functional internal teams

• Prepare project and study documentation, including informed consent forms, CRFs, study guides, training materials, study binders, and patient diaries

• Coordinate data listing reviews and the preparation of interim and final clinical study reports

• Review CRFs, source documentation, procedural data, device accountability records, safety incidents, and other study documentation

• Create study-specific monitoring tools and associated documents

• Deliver monitoring reports, confirmation letters, and follow-up letters within established timelines

• Resolve action items from monitoring visits adhering to monitoring plan timelines

• Review and approve essential regulatory documents across multiple studies

• Aid in tracking study metrics and the execution of clinical trials

• Supervise clinical data and the resolution of queries

• Assist with trial submissions to IRB/IEC and regulatory bodies

• Ensure adherence to study timelines across various studies

• Mentor and coach other Clinical Research Associates

• Maintain a thorough understanding of protocols and product development

• Organize, coordinate, communicate, and manage site activities; escalate issues as necessary

• Verify subject rights, well-being, and informed consent

• Manage device accountability, including storage, inventory, return/destruction, and receipt/disposition records

• Ensure compliance with adverse event and serious adverse event reporting

• Manage documentation, tracking, and escalation of protocol deviations

• Participate in site audits as requested

⛳️ Requirements

• BS/BA degree in a relevant scientific field or equivalent experience

• Over 5 years of experience directly supporting clinical research or related medical/scientific roles

• Minimum of 3 years of CRA experience in medical device or biotech clinical trials

• Preferred experience in cardiovascular, interventional, surgical, image-guided, or ablation devices

• CRA certification such as CCRA or CCRP is highly preferred

• Proficient in Adobe Acrobat, Microsoft Word, Excel, PowerPoint, and Smartsheet

• Ability to quickly gain proficiency in other computer software applications

• Familiarity with FDA and international regulations and guidelines, including GCPs, SOPs, submissions, product launches, labeling, advertising and promotion, product vigilance, and medical device reporting

• Proficient in using EDC and CTMS systems

• Working knowledge of FDA, European Regulatory, and EC procedures, as relevant

• Superior oral and written communication and presentation abilities

• Logical and systematic thinking, sound judgment, and strong problem-solving skills

• Exceptional critical-thinking and analytical capabilities

• Strong organizational skills; ability to work independently, take initiative, manage projects, and suggest actions

• Ability to collaborate as a team member, multitask, and adapt to shifting priorities

• Flexibility in work hours and willingness to travel up to 40% of the time, including potential overnight and international travel

• Capacity to lift 10–15 pounds

🏝️ Benefits

• A range of health insurance plans and supplemental insurance choices

• 401k retirement savings plan

• Stock options awards

• Employee Stock Purchase Plan (ESPP)

• Paid time off

• Paid holidays

• Flexible work hours

• Wellness program, including onsite gym and mindfulness classes

• Opportunities for professional and personal growth and development

• A culture of learning

• A respectful and diverse work environment